Open Label Pilot Study of Apremilast in Treatment of Rosacea

Part of paid clinical trials in New York, New York.

Sponsor
Julian M. Mackay-Wiggan
Study ID
NCT01045551
Phase
PHASE2
Status
Completed

Conditions

  • Erythematotelangiectatic Rosacea
  • Papulopustular Rosacea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    20mg taken orally twice per day for 12 weeks

Study Details

Rosacea is a chronic skin disorder with the signs and symptoms of facial flushing, persistent redness, small visible spider-like veins, papules (inflamed red bumps under the skin) and pustules. Rosacea is also a a recurring skin disorder. In addition to causing uncomfortable and embarrassing physical symptoms such as flushing, burning, and itching, rosacea can also contribute to lower self-esteem, which can have a significant psychosocial impact on quality of life. Rosacea flares can be triggered by every day factors such as sun exposure, heat, hot or caffeinated drinks, alcoholic beverages, spices and stress. Many of the currently available treatments for rosacea are only partially effective and some patients do not respond to them, or are unable to tolerate the side effects. This is a single-center, open label trial of Apremilast in ten (10) subjects with moderate to severe inflammatory rosacea who will be treated with Apremilast 20 mg twice per day for 12 weeks. Following the screening period and baseline visit, study subjects will return at weeks 1, 2, 4, 6, 8, 10 and 12. There is a follow up study visit at week 16. Recent research has shown an increase of specific proinflammatory cytokines in the biopsies of inflammatory lesions from rosacea and acne patients. The cytokines then trigger a chain of chemical responses in the body that likely result in the development of the papules an pustules that are seen in rosacea and acne patients. Apremilast is an oral agent that modulates multiple anti-inflammatory pathways and has pharmacodynamic properties with potential therapeutic benefit for treating inflammatory autoimmune disorders. The investigators therefore propose a pilot study to evaluate the potential for Apremilast to improve the signs and symptoms of moderate to severe inflammatory rosacea.

Key Dates

First listed
Jan 11, 2010
Start date
Jun 30, 2010
Status verified
Oct 2016
Primary completion
Jan 31, 2013
Completion
Apr 30, 2014

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast 20 mg (twice per day)
    All subjects will receive Apremilast 20mg taken orally twice per day.

Primary Outcome Measure

Change From Baseline in the Total Number of Papulopustular Lesions at Week 12 [ Time Frame: Baseline to Week 12 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032-

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Columbia University Medical Center· New York, NY

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